Regulatory Affairs Update: Indonesia

Indonesia: Government Regulation No. 28 of 2024 concerning Implementing Regulations for Law No. 17 of 2023 Concerning Health in Indonesia

Indonesia’s government has officially issued Government Regulation No. 28 of 2024 concerning Implementing Regulation for Law No. 17 of 2023 concerning Health has been officially signed by Indonesia President, Joko Widodo on 26 July 2024. In order to increase health capacity and resilience within the framework of Health transformation to achieve its improvement the highest degree of public health is maintained through health efforts, health resources, and health management which is supported by strengthening regulations through the promulgation Law No. 17 of 2023 concerning Health.

This Government Regulation consists of a total of 1172 articles covering the implementation of health efforts, technical aspects of health services, management of medical personnel and health workers, health service facilities, as well as technical health supplies and pharmaceutical resilience of medical devices.

Here are points that can be highlighted relating to medical device regulations:

Article 414

Pharmaceutical preparations, medical devices and PKRT can only be obtained after obtaining business permits in the form of distribution permit in accordance with statutory provisions.

Article 937

Paragraph 1: Central Government, Regional Government, society, and Health Service Facilities must prioritize use of Pharmaceutical Preparations and Medical Devices in

country while still paying attention to quality, quality, security, and usefulness.

Article 939

Paragraph 1: To support the production of Domestic Pharmaceutical Preparations and Medical Devices, the government and regional governments must provide incentives to the Pharmaceutical Preparations industry and Medical Devices and business actors who make efforts to realize the resilience of Pharmaceutical Supplies and Medical devices.

Article 940

Paragraph 1: Central Government and Regional Government Facilitate the technology transfer process required in the Production of Pharmaceutical Preparations and Medical Devices.

Paragraph 2: Facilitation of the technology transfer process is prioritized increasing industrial manufacturing capabilities domestically to meet national, regional, and global needs.

Paragraph 3: The Central Government and Regional Governments can Facilitate funding for public and private partnerships in the development of the Pharmaceutical Preparations industry and

Domestic Medical Devices are still in their initial stages and are currently developing.

Paragraph 4:  Providing support is also possible through foreign cooperation carried out by the Central government, Regional Government, and/or the public.

Paragraph 5: Foreign cooperation as aimed at increasing investment, human resources, as well as industrial production capacity

The newly issued regulation can be accessed here (in Bahasa Indonesia) please visit this link.

Should you have any inquiries or require further assistance, please do not hesitate to contact us at sales@andamanmed.com or click the button below.

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